The following data is part of a premarket notification filed by Medtrex, Inc. with the FDA for O.r.pro 300 Electrosurgical Generator Model 40001-100.
| Device ID | K981724 |
| 510k Number | K981724 |
| Device Name: | O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTREX, INC. 9712 S. ALTAMONT DR. Sandy, UT 84092 |
| Contact | William E Mckay |
| Correspondent | William E Mckay MEDTREX, INC. 9712 S. ALTAMONT DR. Sandy, UT 84092 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-15 |
| Decision Date | 1998-06-22 |
| Summary: | summary |